Response of Patients on Surveillance for Prostate Cancer to Dutasteride

NCT ID: NCT01525914

Last Updated: 2012-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer.

The study will determine the prevalence of a secondary rise in PSA \> 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.

Detailed Description

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This analysis is a subset of the data associated with the active surveillance cohort at Sunnybrook Health Sciences Centre. Approximately 150 subjects within the cohort have received dutasteride therapy from 6 months to 3 years. All subjects have had serial PSAs at regular intervals between 3 to 6 months, and all have had a biopsy performed within 1 to 3 years of initiating dutasteride. The prevalence of a secondary rise in PSA \> 0.5ng/ml will be calculated with the impact of dutasteride therapy on the PSA doubling time. This information will be correlated with baseline PSA value, prostate volume, extent of disease on initial biopsy and baseline PSA kinetics. PSA kinetics will be also correlated with Gleason score upgrading on repeat biopsy. The rate of negative biopsies in men on dutasteride therapy will be compared with a similar group of surveillance subjects not treated with dutasteride.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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dutasteride, active surveillance

men with favorable risk prostate cancer on surveillance treated with dutasteride

Dutasteride

Intervention Type DRUG

dutasteride 0.5mg daily

Interventions

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Dutasteride

dutasteride 0.5mg daily

Intervention Type DRUG

Other Intervention Names

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Avodart

Eligibility Criteria

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Inclusion Criteria

* Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Toronto Sunnybrook Regional Cancer Centre

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Dr. Laurence Klotz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurence Klotz, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CRT114918

Identifier Type: -

Identifier Source: org_study_id

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